Discharge Conditions of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl

NCT ID: NCT01880775

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-07-31

Brief Summary

In this prospective randomized study the investigators aimed to investigate difference of the duration of spinal anesthesia, discharge times and efficacy between low dose heavy Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery.

Detailed Description

ASA status I-III patients will be recruited. Patients will be randomized in two groups. Group B will be received 1.5 ml heavy bupivacaine+ 20 mic fentanyl+ 0.15 ml and Group P will be received 1,5 ml heavy prilocaine+20 mic fentanyl in the same volume.Patients will be monitored with electrocardiography, peripheral oxygen saturation(sPO2) and non invasive blood pressure (Drager Infinity Delta; 16 Electronics Avenue, Danvers, MA 01923 USA). After inserting a 20 G intravenous line the patients will be hydrated with 10 ml/kg 0.9 % saline.

Preoperative systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR) and Spo2 will be measured and recorded.

Spinal anesthesia will be commenced in the sitting position with a 25 G Quincke needle, with the midline approach. After observing free flow of cerebrospinal fluid the prepared study drug will be injected in 15 seconds. The patients will be placed supine after waiting 2 minute in the sitting position. Supplemental oxygen via nasal cannula will be provided.

Fentanyl and midazolam will be used for rescue analgesia and sedation and recorded.

Sensorial block will be assessed with pinprick test with 2 minute intervals until the maximum block achieves and with 15 minute intervals until the block was regresses to S3 dermatome. Motor block will be assessed with the Bromage score when the block reached the maximum level. Patients will be transferred to postoperative care unit (PACU) at he end of surgery.

Pain will be assessed on a 10 point visual analog scale (VAS)(0= no pain, 10= worst pain ever). Postoperative analgesia will be provided with 2 mg.kg-1 tramadol or 15 mg.kg-1 paracetamol when the VAS score is ≥3 time of first analgesic request will be recorded.

Hypotension (≥20% reduced from baseline values) will be treated with ephedrine or iv fluid boluses), bradycardia (HR<45 beat min-1 was treated with atropine) was recorded.

The patients will be asked whether to void before surgery. Bladder volume will be assessed with ultrasonography. Patients with residual bladder volumes ≥400 ml will be placed an urine catheter. Time to first urinate will be recorded.

Patients will be assessed for transient neurologic symptoms(pain in the buttocks and legs)(TNS) and satisfaction after surgery.

TNS will be evaluated with daily telephone calls. Patient satisfaction will be evaluated with global satisfaction scale (1= bad, 2=not satisfied, 3=have no idea, 4=satisfied, 5=very satisfied) Parameters to record; time of entering operation room, duration of surgery, time of intrathecal injection, onset of sensorial block(block at L1), time to reach maximum block level, maximum block level, first analgesic ingestion time, PACU duration, two segment regression, time to L1 regression, time to S3 regression, time to it without help, time to stand up without help, time to walk without help, discharge time, time to first void. TNS, patient satisfaction score.

Conditions

Hemorrhoid; Peri Anal Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

prilocaine heavy 2%& fentanyl

prilocaine heavy 2% 30 mg and fentanyl 20 micgr ampoule intrathecal

Group Type: EXPERIMENTAL

Prilocaine

Intervention Type: DRUG

experimental

bupivacaine heavy 0.5% & fentanyl

bupivacaine heavy 0.5% 7.5 mg and fentanyl 20 micg ampoule intrathecal

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

marcaine heavy 0.5% 7.5 mg intrathecal

Interventions

Prilocaine

experimental

Intervention Type: DRUG

Bupivacaine

marcaine heavy 0.5% 7.5 mg intrathecal

Intervention Type: DRUG

Other Intervention Names

prilothecal; citanest; marcaine heavy 0.5%

Eligibility Criteria

Inclusion Criteria

• ASA status I-III

Exclusion Criteria

• Patients with contraindications for spinal anesthesia,
• hypersensitivity to study drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ozden Gorgoz Kaban

Medical Doctor Trainee in Anesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taylan Akkaya, Assoc Prof.

Role: STUDY_DIRECTOR

Ministry of Health

Locations

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.

Reference Type: BACKGROUND

PMID: 20529983 (View on PubMed)

Black AS, Newcombe GN, Plummer JL, McLeod DH, Martin DK. Spinal anaesthesia for ambulatory arthroscopic surgery of the knee: a comparison of low-dose prilocaine and fentanyl with bupivacaine and fentanyl. Br J Anaesth. 2011 Feb;106(2):183-8. doi: 10.1093/bja/aeq272. Epub 2010 Oct 14.

Reference Type: BACKGROUND

PMID: 20947591 (View on PubMed)

Ostgaard G, Hallaraker O, Ulveseth OK, Flaatten H. A randomised study of lidocaine and prilocaine for spinal anaesthesia. Acta Anaesthesiol Scand. 2000 Apr;44(4):436-40. doi: 10.1034/j.1399-6576.2000.440413.x.

Reference Type: BACKGROUND

PMID: 10757577 (View on PubMed)

Other Identifiers

OKabanPrilocain

Identifier Type: -

Identifier Source: org_study_id